Regulatory Affairs Job at Genpact in Mumbai | Freshers Apply
If you’re exploring a regulatory affairs job that combines compliance expertise with cutting-edge technology, this opportunity at Genpact offers the perfect launchpad. As digital innovation reshapes industries, this role positions you at the heart of Genpact’s transformation engine – making it one of the most promising paths in Genpact careers for professionals seeking impactful jobs in Mumbai within the regulatory domain.
Regulatory Affairs Job Details:
- Job Position: Technical Associate – Regulatory Affairs (LIF022201)
- Job Category: Full Time
- Master Skills List: Operations
- Job Location: Mumbai
About the Company
Genpact is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Known for accelerating Genpact careers through AI-driven innovations, the company empowers talent to create meaningful impact across diverse industries. With its AI Gigafactory and digital transformation initiatives, Genpact is shaping the future of work—making it an ideal destination for professionals seeking strong jobs in Mumbai and transformative regulatory roles.
Minimum Qualifications
- Bachelor’s degree, preferably in Medicine, with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guidelines for the US market.
- Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
- Should have an advanced level in the English language.
- In-depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
- Effective time management and organizational skills.
- Effective communication.
- Flexibility to adapt to a changing environment.
Preferred Qualifications / Skills
- Enthusiasm & confidence
- Adhere to the principles and values
- Time Management Skills
Job Description
Genpact is inviting applications for the role of Technical Associate, Publisher for US market – Regulatory Affairs – Operations. This opportunity is ideal for candidates looking to grow in a regulatory affairs job and establish a long-term pathway within Genpact careers. In this role, you should be a fresher or have a minimum of years of experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Regulatory Affairs Job – Key Responsibilities
- The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.
- Publishing and performing technical validation of eCTD for US submissions.
- Performing final technical quality review.
- Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgement from the authority of submission receipt, capturing and the electronic receipt and metadata in RIM, and communicating submission receipt to key stakeholders.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
